Vaccine Therapy With or Without Fludarabine in Treating Patients With Stage IV Kidney Cancer

NCT00093522 | Unknown Phase 2

• 3 other identifiers: CDR0000389145STLMC-IMM-03-05STLMC-L-03-138
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with fludarabine may kill more tumor cells. PURPOSE: This randomized phase II trial is studying vaccine therapy and fludarabine to see how well they work compared to vaccine therapy alone in treating patients with stage IV kidney cancer.

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (3)

• Safety as measured by NCI common toxicity table at completion of study

• Response as measured by RECIST guidelines and the Kaplan-Meier method at 5 years

• Survival as measured by the Kaplan-Meier method at 5 years

Interventions

autologous tumor cell vaccine BIOLOGICAL

keyhole limpet hemocyanin BIOLOGICAL

therapeutic autologous dendritic cells BIOLOGICAL

fludarabine phosphate DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Stage IV disease * Received no benefit from standard therapy OR ineligible for standard therapy OR declined standard therapy * At least 1 site of metastatic disease that can be surgically removed AND at least 1 site of metastatic disease than can remain in the patient (indicator lesion) after surgery * Total volume of the site or sites of disease to be surgically removed must be \> 2.0 cm\^3 * Unidimensionally measurable disease * At least 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * No brain metastasis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * More than 6 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Hemoglobin ≥ 10 g/dL Hepatic * SGPT and SGOT ≤ 2.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Hepatitis C antibody negative * Hepatitis B surface antigen negative Renal * Creatinine ≤ 1.5 times ULN * Creatinine clearance \> 40 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Immunologic * Coomb's test negative * HIV-1 and -2 negative * No active infection * No unexplained fever (temperature \> 100.5° F or 38.1°C) * No lymphocytopenia * No hypogammaglobulinemia * No autoimmune disease or other immunocompromising condition that would preclude study participation * No history of impaired immune response * No history of tuberculosis OR positive PPD skin test * No history of allergic reaction attributed to compounds of similar biological composition to study vaccine * No history of allergic reaction to antibiotics Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 month after study participation * No psychiatric illness or social situation that would preclude study participation * No other malignancy within the past 5 years except resected basal cell carcinoma or carcinoma in situ of the cervix * No other concurrent illness PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy * At least 4 weeks since prior steroid therapy or steroid-containing compounds * At least 2 weeks since prior topical or inhaled steroids Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * See Disease Characteristics Other * More than 4 weeks since prior investigational agents * More than 1 week since prior antibiotics * No concurrent renal dialysis * No concurrent anticoagulants * No other concurrent anticancer agents or therapies * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• St. Luke's Medical Center: lead

Study Sites (2)

Midwest Heart Surgery Institute, Limited

Milwaukee, Wisconsin, 53215, United States

Location

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

FANG vaccine; keyhole-limpet hemocyanin; fludarabine phosphate

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• John P. Hanson, MD

  St. Luke's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2004
• First Posted: October 8, 2004
• Study Start: August 1, 2004
• Last Updated: December 19, 2013

Record last verified: 2007-05

Locations

US (2)